Breathing-Maneuver-Induced Myocardial Oxygenation Reserve Validated by FFR (B-MORE)

NCT ID: NCT04126148

Last Updated: 2024-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-04

Study Completion Date

2024-12-31

Brief Summary

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The study aims to determine a diagnostic marker for regionally impaired myocardial oxygenation response in patients with suspected coronary artery stenosis.

Detailed Description

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This observational applied research international study aims to assess the validity of breathing maneuvers as a vasoactive maneuver and Oxygenation-Sensitive Cardiac Magnetic Resonance Imaging (OS-CMR) in a patient population. OS-CMR results will be compared to the clinical gold standard of Fractional Flow Reserve (FFR) and instant wave-free ratio (iFR) as a secondary objective, to determine if this non-invasive, no pharmaceutical agent imaging technique can identify areas of oxygenation deficit in myocardium perfused by a stenosed coronary artery.

Conditions

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Coronary Artery Stenosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Age matched Healthy participants (150)

Healthy Participants Age: \> 40y No known current or pre-existing significant medical problems that would affect the cardiovascular or respiratory system

No interventions assigned to this group

Coronary Artery Disease (CAD) Patients (200)

Coronary Artery Disease (CAD) Patients Age \> 18 y Patients with an Indication for invasive coronary angiography based on symptoms and a test positive for inducible coronary ischemia, or previous coronary angiography.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Healthy Participants

* Age: \> 40y
* No known current or pre-existing significant medical problems that would affect the cardiovascular or respiratory system.

CAD Patients

* Age \> 18 y
* Indication for invasive coronary angiography based on symptoms and a test positive for inducible coronary ischemia, or previous coronary angiography.

Exclusion Criteria

ALL participants:

* General MRI contraindications: Pacemakers, defibrillating wires, implanted defibrillators, intracranial aneurysm clips, metallic foreign bodies in the eyes, knowledge or suspicion of pregnancy.
* Consumption of caffeine (coffee, tea, cocoa, chocolate, "energy drink") during the 12 hours prior to the exam.
* Regular nicotine consumption during the last 6 months.

Patients only

* Vasoactive medication (e.g. nitro) during the 12 hours prior to the exam Contraindications to adenosine (2nd or 3rd A-V block, sinus node disease, asthma, bronchoconstrictive diseases).
* Acute Coronary Syndrome (ACS), or previous Coronary Artery Bypass Surgery
* Previous myocardial infarction within 1 month
* Clinically unstable condition
* Significant or uncontrolled arrhythmia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role lead

Responsible Party

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Matthias Friedrich

Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthias G Friedrich, MD

Role: PRINCIPAL_INVESTIGATOR

Reseach Institute of the McGill University health Center

Locations

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McGill University Health Center

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Elizabeth Konidis

Role: CONTACT

514 934-1934 ext. 37305

Adonis Rodaros

Role: CONTACT

514 934-1934 ext. 37305

Facility Contacts

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Matthias G Friedrich, MD

Role: primary

514 934-1934

Elizabeth Konidis

Role: backup

514 934-1934 ext. 37305

Other Identifiers

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2019-4137

Identifier Type: -

Identifier Source: org_study_id

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